Double-blind, Randomized, Placebo-controlled Phase 3 Study of Etanercept in the Treatment of Psoriatic Arthritis and Psoriasis

Subjects had to satisfy the following criteria before randomization into the study: • Active PsA at the time of screening, including ≥ 3 swollen joints and ≥ 3 tender/painful joints. • Had ≥ 1 of the following subtypes of PsA: distal interphalangeal (DIP) involvement; polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); arthritis mutilans; asymmetric peripheral arthritis; or ankylosing spondylitis-like. • Arthritis had demonstrated an inadequate response to nonsteroidal antiinflammatory drug (NSAID) therapy. • Subjects had plaque psoriasis with qualifying target lesion. Target lesion was to be ≥ 2 cm in diameter and could not be on the scalp, axilla, or groin. Psoriasis was to be stable (ie, not accelerating). • Between 18 and 70 years of age. • Subjects remaining on concomitant MTX (≤ 25 mg/week) had inadequate disease control in the opinion of the investigator and had been on a stable dose of MTX for 2 months before start of investigational product. Subjects were required to maintain a stable dose of MTX throughout the study. • Negative serum pregnancy test within 14 days before the first dose of investigational product in all women (except those surgically sterile or ≥ 5 years postmenopausal). • Heterosexually active men and women of childbearing potential agreed to use a medically accepted form of contraception throughout the study, including the exclusionary medicine washout period and follow-up period. • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2 times laboratory's upper limit of normal; hemoglobin ≥ 8.5 g/dL; platelet count ≥ 125,000/mm3; white blood cell count ≥ 3,500 cells/mm3; and serum creatinine ≤ 2 mg/dL. • Negative HIV test. Negative test for hepatitis B surface antigen and hepatitis C. • Able to reconstitute and self-inject investigational product or have a designee who could do so. • Capable of understanding and giving written, voluntary informed consent.

• Guttate or pustular psoriasis. • Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. • Active severe infection within 1 month of investigational product administration. • Subjects must be off antibiotics for 1 week before investigational product administration. • Previous receipt of etanercept, known antibody to TNF, or experimental metalloproteinase inhibitors (past or current use of minocycline and doxycycline was acceptable). • Receipt of investigational drugs or biologics within 4 weeks of the screening visit. • Receipt of anti-CD4 or diptheria IL-2 fusion protein within the previous 6 months, with a subsequent abnormal absolute T cell count. • Psoralen ultraviolet A phototherapy (PUVA) within 4 weeks of investigational product initiation. Ultraviolet B (UVB) phototherapy within 2 weeks of investigational product initiation. • Receipt of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX (eg, hydroxycholorquine, oral or injectable gold, cyclophosphamide, cyclosporine, azathioprine, D-penicillamine, or sulfasalazine) or intra-articular corticosteroids within 4 weeks before the first dose of investigational product. • Dose of NSAID greater than the maximum recommended dose in the product information. NSAID dose had to be stable for ≥ 4 weeks before screening evaluation. • Concomitant corticosteroids > 10 mg/day of prednisone (or its equivalent). Corticosteroid dose had to be stable for ≥ 4 weeks before screening evaluation. • Topical steroids, oral retinoids, topical vitamin A or D analog preparations or anthralin within 14 days of baseline. (Exception: Topical therapies were permitted on scalp, axillae, and groin but had to be stable throughout trial.) • Pregnancy or lactation in women. • Significant concurrent medical diseases including: - Diabetes mellitus requiring insulin - Uncompensated congestive heart failure - Myocardial infarction within 12 months of screening visit - Unstable or stable angina pectoris - Uncontrolled hypertension - Severe pulmonary disease (requiring medical or oxygen therapy) - History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) within 5 years of screening visit - HIV positive, hepatitis B surface antigen, or hepatitis C positive - Rheumatoid arthritis, systemic lupus, scleroderma, or polymyositis - Any condition judged by the subject’s physician that would cause this study to be detrimental to the subject • Current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent. • History of alcohol or drug abuse that would interfere with ability to comply with the study protocol.